An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.

SPH7485-101

To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.

2024-07-31

2027-12-31

2027-12-31

Not yet recruiting

Early phase I

170

Inclusion Criteria: 1. Histologically or cytologically confirmed advanced solid tumors； 2. At least one extracranial measurable lesion; 3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1; 4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period; 5. Life expectancy≥3 months; 6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1; 7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception; 8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures. Exclusion Criteria: 1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose; 2. Subjects who have received previous drugs with the same target; 3. Subjects with active infections requiring systemic treatment; 4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods; 5. Subjects with uncontrolled or severe cardiovascular disease; 6. Severe lung disease; 7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug; 8. Subjects taking strong/moderate inhibitors or inducers of CYP3A4; 9. Subjects who use or require long-term use of hormonotherapy before screening; 10. Subjects who have had other malignancies within the past 5 years; 11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis; 12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery; 13. Abnormal virological examination during screening; History of immune deficiency; 14. Uncontrolled systemic diseases; 15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose; 16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose; 17. Subjects with a history of severe allergy or known allergy to this product and its excipients; 18. Subjects who cannot follow the study protocol to complete the required study visit and dosing; 19. Subjects with a history of alcohol or drug abuse; 20. Lactating female patients; 21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator; 22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

2024-07-04